Reported Feb 4, 2026 · Ongoing
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Brand NameElekta
- Medical Linear Accelerator Product NameElekta Synergy, Elekta Harmony, Elekta Infinity
- Versa HD Software VersionN/A
- Product DescriptionDigital
- Linear Accelerator ComponentNo
- Lot codes and dates
- Lot Code05060191071550 (NFB) Elekta Synergy 05060191071505 (FB) 05060191071543 (NFB) Elekta Infinity 05060191071512 (FB) 05060191071574 (NFB) Versa HD 05060191071529 (FB) 05060191071581 Harmony 05060191071604 Harmony Pro 07340201503461 Elekta Evo
- Amount recalled
- 5391
Why it was recalled
Due to a manufacturing issue and electrical grounding of systems.
This product could cause temporary or reversible health problems — stop using it.
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